Robotic prostatectomy – The way forward or is the jury still out ?

Robotic prostatectomy – the way forward or is the jury still out?

Mr Nikhil Vasdev

Post CCT Robotic Urological Fellow

(RCSEng/ BAUS National Accredited Fellowship programme) Hertfordshire and South Bedfordshire Urological Cancer Centre

Lister Hospital Stevenage

Faculty in Robotic Urology

Chitra Sethia Robotic Centre UCL

London

Hilton Doubletrees HotelDunblaneTuesday the 22nd October 6.00pm – 8.55pm

To register please email [email protected]

This medical education meeting is organised and supported by Janssen

©Janssen-Cilag LtdPHGB/MEDed/0913/0001 Date of Preparation: September 2012

CPD accreditation has been applied for.

INVITATIONProstate Cancer

Evening Symposium

Dunblane-INVITE_Layout 1 05/09/2013 08:07 Page 1

Conflicts of Interest

!   Nil

!   Nil

Financial disclosures

Introduction !   Men with localized prostate cancer can be offered a radical

prostatectomy

!   The types of prostatectomy being offered in the UK

!   Open radical prostatectomy (ORP)

!   Laparoscopic radical prostatectomy (LRP)

!   Robotic radical prostatectomy (RRP)

! Perineal prostatectomy (RPP)

!   Baseline problems in finding evidence for superiority

!   A Randomized clinical trial is not feasible because both expert

surgeons and patients have their bias regarding the optimal technique

!   No level 1 evidence !   Different definitions – Positive margins, biochemical recurrence,

urinary incontinence and sexual function

!   Limited to single case series, systematic reviews and meta-analysi

!   Selection bias in these studies often from high volume, academic centers

Aim !   To evaluate the safety and efficacy of RRP in comparison to

ORP and LRP

Comparative effectiveness research (CER)

RRP

ORP LRP

Aim of prostate cancer surgery

ORP / LRP RRP

Trifecta Pentafecta

Disease control Disease control

Potency Potency

Continence Continence

Negative Margins

Complications

Objective criteria considered

!   Cancer cure rates (In intermediate and high risk groups)

!   Positive surgical margin rates

!   Urinary continence

!   Erectile dysfunction rates

! Peri-operative morbidity

!   Post-operative complications

!   Costs

Nature Reviews Urology 2004 Technology Insight: surgical robots Expensive toys or the future of urologic surgery? ‘‘A Robot Saved My Life’’: Is It a Myth?

Premature Robotic Surgery: Putting Patients and Professionals at Risk

Robotic Surgery: Hope or Hype? Presidential Debate SAGES 2011

Will the Future of Health Care Lead to the End of the Robotic Golden Years?

Robotic Surgery – Current trend

Robotic technology has been adopted rapidly over the past 4 years in both the United States and Europe. The number of robot-assisted procedures that are performed worldwide has nearly tripled since 2007, from 80,000 to 205,000. Between 2007 and 2009, the number of da Vinci systems75%, from almost 800 to around 1400, and the number that were installed in other countries doubled, from 200 to nearly 400

1999 2000 2001 2002 2003

da Vinci® European Installed Base 1999 – 2012

2004 2005 2006 2007 2008 2009 2010-12

da Vinci® USA Installed Base 1999 – 2012

Surgical Advantages of Robotic Surgery

Surgical Advantages of Robotic Surgery

10 X magnification

Surgical disadvantages of robotic surgery

!   Lack of haptic feedback

!   Cost

Surgical disadvantages of robotic surgery

!   Positional injuries and anaesthetic/physiological repercussions of the steep trendelenburgh position

MIRP vs. ORP undergoing Surgery 2003-2007

All analyses were performed with SASversion 9.1.3 (SAS Institute Inc, Cary,North Carolina).

RESULTSAmong the 8837 men undergoingradical prostatectomy, use of MIRPincreased almost 5-fold from 9.2%(95% confidence interval [CI], 8.1%-10.5%) in 2003 to 43.2% (95% CI,3 9 . 6 % - 4 6 . 9 % ) i n 2 0 0 6 - 2 0 0 7(FIGURE). The number of surgeriesperformed in 2006 and 2007 appearsto have decreased because data onnew cancer diagnoses were availableonly through 2005. We observedsociodemographic differences amongmen undergoing MIRP vs RRP(Table 1). Relatively fewer menrecorded as black (6.2% vs 7.8%) andHispanic (5.6% vs 7.9%) underwentM I R P v s R R P , w h e r e a s t h o s erecorded as Asian were more likely(6.1% vs 3.2%) to undergo MIRP vsRRP (P ! .001). In addition, menwho underwent MIRP vs RRP weremore likely to live in areas with atleast 90% high school graduationrates (50.2% vs 41.0%) and medianhousehold income of at least $60 000(35.8% vs 21.5%) (all P! .001).

We also observed geographic varia-tion, with relatively greater use of MIRPvs RRP in the Detroit, Michigan (14.7%vs 5.6%), Los Angeles, California(13.5% vs 10.4%), and greater Califor-nia (26.8% vs 23.8%) tumor regis-tries. Moreover, the Detroit and Cali-fornia tumor registries contributedalmost two-thirds of the MIRP vs lessthan half of the RRP cohort. In addi-tion, men undergoing MIRP vs RRPmore often lived in metropolitan vsnonmetropolitan areas (95.3% vs91.2%; P=.007). While pathologic tu-mor grade was similar, men undergo-ing MIRP vs RRP were more likely tohave organ-confined disease (68.3% vs60.8%; P! .001).

Ten men (0.5%) vs 58 men (0.8%)died within 1 year of MIRP vs RRP sur-gery (P=.17), and the mortality rate didnot differ through the remainder of ourstudy (0.8 vs 0.9 per 100 person-years; P=.72). Patients were censored

from analysis at the time of death, andmedian follow-up was 2.8 years (range,1 day to 5 years). Unadjusted associa-tions are presented in TABLE 2. Resultsare generally consistent with ad-justed associations. In the propensity-adjusted analyses (TABLE 3), men un-dergoing MIRP vs RRP experiencedshorter length of stay (median, 2.0 vs3.0 days; OR, 0.67; 95% CI, 0.58-0.72), were less likely to receive heter-ologous transfusions (2.7% vs 20.8%;OR, 0.11; 95% CI, 0.06-0.17), and wereat lower risk of postoperative respira-tory complications (4.3% vs 6.6%; OR,0.63; 95% CI, 0.46-0.87), miscella-neous surgical complications (4.3% vs5.6%; OR, 0.75; 95% CI, 0.56-0.99), andanastomotic stricture (5.8% vs 14.0%;OR, 0.38; 95% CI, 0.28-0.52).

However, men undergoing MIRP vsRRP experienced more genitourinarycomplications (4.7% vs 2.1%; OR, 2.28;95% CI, 1.61-3.22) and were more of-ten diagnosed as having incontinence

(15.9 vs 12.2 per 100 person-years; OR,1.3; 95% CI, 1.05-1.61) and erectile dys-function (26.8 vs 19.2 per 100 person-years; OR, 1.4; 95% CI, 1.14-1.72). The

Figure. Use of Minimally Invasive vs OpenRetropubic Radical Prostatectomy for MenDiagnosed as Having Prostate Cancer in2002-2005 and Undergoing Surgery in2003-2007

1009080

4050

7060

3020100

No. of patientsMinimally

invasiveRetropubic

2003

244

2394

2004

542

2218

2005

843

1881

2006-2007(Combined)

309

406

Year of Surgery

Rad

ical

Pro

stat

ecto

my,

%

Minimally invasiveRetropubic

Radical prostatectomy

Table 2. Unadjusted Outcomes by Surgical ApproachMIRP RRP P Value

Length of stay, median (IQR) 2 (1-2) 3 (2-4) !.001Heterologous blood transfusion, No. (%) 49 (2.5) 1383 (20.1) !.00130-Day postoperative complications, No. (%)

Overall 422 (21.9) 1606 (23.4) .31Cardiac 39 (2.0) 206 (3.0) .03Respiratory 80 (4.2) 465 (6.8) !.001Genitourinary 77 (4.0) 150 (2.2) !.001Wound 31 (1.6) 129 (1.9) .41Vascular 56 (2.9) 265 (3.9) .08Miscellaneous medical 181 (9.4) 598 (8.7) .49Miscellaneous surgical 91 (4.7) 387 (5.6) .15Death 2 (0.1) 12 (0.2) .46

Anastomotic stricture, No. (%)a 99 (5.3) 946 (14.2) !.001Incontinence per 100 person-yearsb

Diagnosis 18.2 11.9 !.001Procedures 9.5 8.5 .30

Erectile dysfunction per 100 person-yearsb

Diagnosis 33.8 18.2 !.001Procedure 2.8 2.1 .04

Additional cancer therapy per 100 person-yearsOverall 6.1 6.9 .18Radiation 4.3 4.9 .16Hormone 3.5 3.7 .58

Death during the study period 0.7 0.9 .11Abbreviations: IQR, interquartile range; MIRP, minimally invasive radical prostatectomy; RRP, open retropubic radical

prostatectomy.aMen who underwent surgery in 2007 were excluded because of insufficient follow-up to capture this outcome.bMen who underwent surgery in the latter half of 2006 through the end of 2007 were excluded because of insufficient

follow-up to capture this outcome.

MINIMALLY INVASIVE VS OPEN RADICAL PROSTATECTOMY

©2009 American Medical Association. All rights reserved. (Reprinted) JAMA, October 14, 2009—Vol 302, No. 14 1561

Hu J et al, JAMA, 2009, Vol 302

Oncological Outcomes

!   13 years since the first robotic procedure

!   Few centres have follow up of more than 5 years

!   Current data indicates that the BCR-free survival estimates

!   95.1% at 1 year

!   90.6% at 3 years

!   86.6% at 5 years

!   81.0% at 7 years

Oncological Outcomes

! Badani et al, 7.2% PSA recurrence rate with a 5 year actuarial biochemical free survival of 84% of this series

!   Despite of differences , given the relative follow up for RRP it is difficult to comment of the superiority of which technique is better

Cancer Control - Selected large RPseries Technique and series No of

patients pT2,% Overall PSM,

% BDFS,% 5 year

BDFS,% 10 year

10 year CSS, %

Open RRP

Han et al 2404 51 11 92 85 96

Roehl et al 3478 61 80 68 97

Chun et al 4277 64.3 21.5 70 61

Lap RP

Guillonneau et al 1000 77.5 19.2 90(3yrs)

Stolzenberg et al 700 55.4 19.8

Lein et al 1000 70.2 26.8

RALP

Menon et al 2652 77.7 13

Mottrie et al 184 65.5 15.7

Patel et al 500 78 9.4

Sooriakumaran et al 944 74% 22% 87% 83% 98%

!   Silberstein compared early oncological outcomes of 961 ORP and 493 RRP

!   This study is a convincing study, short of a randomised trial, that suggests that in experienced hands both techniques can be effective, and that surgeon experience had a stronger effect than technique [Data from 4 high volume centres]

!   RRP surgeons are five times more likely to omit pelvic LNDs than open, even for high-risk cancers

Positive Surgical Margin

!   The presence of a PSM has a significant effect on prostate cancer progression

!   The positive surgical margin rate was 20% for ORP versus 16.7% for RALRP in a study by Ahlering and coworkers

!   Smith and colleagues retrospectively reviewed 200 procedures from each approach. The overall incidence of positive surgical margins was significantly lower among the RALRP cohort compared with ORP cases (15% vs 35%, P < .001)

Relative effectiveness of robot-assisted andstandard laparoscopic prostatectomy asalternatives to open radical prostatectomyfor treatment of localised prostate cancer:a systematic review and mixed treatmentcomparison meta-analysisClare Robertson, Andrew Close*, Cynthia Fraser, Tara Gurung, Xueli Jia,Pawana Sharma, Luke Vale†, Craig Ramsay and Robert Pickard‡

Health Services Research Unit, University of Aberdeen, Aberdeen, *School of Biology, †Institute of Health and Society,and ‡Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, UK

Re-use of this article is permitted in accordance with the Terms and Conditions set out athttp://wileyonlinelibrary.com/onlineopen#OnlineOpen_Terms

Objective• To compare the e!ectiveness of robot-assisted and standard

laparoscopic prostatectomy.

Methods• A care pathway was described.• We performed a systematic literature review based on a

search of Medline, Medline in Process, Embase, Biosis,Science Citation Index, Cochrane Controlled Trials Register,Current Controlled Trials, Clinical Trials, WHOInternational Clinical Trials Registry and NIH Reporter, theHealth Technology Assessment databases, the Database ofAbstracts of Reviews of E!ects, and relevant conferenceabstracts up to 31st October 2010). Additionally, referencelists were scanned, an expert panel consulted, and websitesof manufacturers, professional organisations, and regulatorybodies were checked.

• We selected randomised controlled trials (RCTs) andnon-randomised comparative studies, published after 1stJanuary 1995, including men with localised prostate cancerundergoing robot-assisted or laparoscopic prostatectomycompared with the other procedure or with openprostatectomy. Studies where at least 90% of included menhad clinical tumour stages T1 to T2 and which reported atleast one of our specified outcomes were eligible forinclusion.

• A mixed-treatment comparison meta-analysis wasperformed to generate comparative statistics on specifiedoutcomes.

Results• We included data from 19 064 men across one RCT and 57

non-randomised comparative reports.• Robotic prostatectomy had a lower risk of major

intra-operative harms such as organ injury [0.4% robotic vs2.9% laparoscopic], odds ratio ([OR] {95% credible interval[CrI]} 0.16 [0.03 to 0.76]), and a lower rate of surgicalmargins positive for cancer [17.6% robotic vs 23.6%laparoscopic], OR [95% CrI] 0.69 [0.51 to 0.96]). There wasno evidence of a di!erence in the proportion of men withurinary incontinence at 12 months (OR [95% CrI] 0.55 [0.09to 2.84]). There were insu"cient data on sexual dysfunction.

• Surgeon learning rates for the procedures did not di!er,although data were limited.

Conclusions• Men undergoing robotic prostatectomy appear to have

reduced surgical morbidity, and a lower risk of a positivesurgical margin, which may reduce rates of cancerrecurrence and the need for further treatment, butconsiderable uncertainty surrounds these results.

• We found no evidence that men undergoing roboticprostatectomy are disadvantaged in terms of earlyoutcomes.

• We were unable to determine longer-term relativee!ectiveness.

Keywordsprostate cancer, robotic surgery, laparoscopic surgery,systematic review, meta-analysis

BJU Int 2013; 112: 798–812© 2013 The Authors

BJU International © 2013 BJU International | doi:10.1111/bju.12247wileyonlinelibrary.com Published by John Wiley & Sons Ltd. www.bjui.org

PSM Robotic Prostatectomy PSM laparoscopic Prostatectomy

17.6%

23.6%

New techniques to reduce PSM during Robotic Prostatectomy

Surgery in Motion

Neurovascular Structure-adjacent Frozen-section Examination(NeuroSAFE) Increases Nerve-sparing Frequency and ReducesPositive Surgical Margins in Open and Robot-assistedLaparoscopic Radical Prostatectomy: Experience After 11 069Consecutive Patients

Thorsten Schlomm a,b,y,*, Pierre Tennstedt a,y, Caroline Huxhold a,y, Thomas Steuber a,Georg Salomon a, Uwe Michl a, Hans Heinzer a, Jens Hansen a, Lars Budaus a, Stefan Steurer c,Corinna Wittmer c, Sarah Minner c, Alexander Haese a, Guido Sauter c, Markus Graefen a,Hartwig Huland a

a Martini-Clinic, Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; b Department of Urology, Section for

Translational Prostate Cancer Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; c Institute of Pathology, University Medical

Center Hamburg-Eppendorf, Hamburg, Germany

E U R O P E A N U R O L O G Y 6 2 ( 2 0 1 2 ) 3 3 3 – 3 4 0

ava i lable at www.sciencedirect .com

journal homepage: www.europeanurology.com

Article info

Article history:Accepted April 29, 2012Published online ahead ofprint on May 10, 2012

Keywords:ProstateProstate cancerNerve-sparing radicalprostatectomySurgeryNerve-sparingFrozen sectionSurgical marginPropensity score

Please visitwww.europeanurology.com andwww.urosource.com to view theaccompanying video.

Abstract

Background: Intraoperative frozen-section analysis allows real-time histologic assess-ment of surgical margins (SMs) and identification of candidates for nerve-sparing (NS)procedures.Objective: To examine the efficacy and oncologic safety of a systematic neurovascularstructure-adjacent frozen-section examination (NeuroSAFE) during NS radical prosta-tectomy (RP).Design, setting, and participants: From January 2002 to June 2011, 11 069 consecutiveRPs were performed at the University Medical Center Hamburg-Eppendorf. Of these,5392 (49%) were conducted with NeuroSAFE.Surgical procedure: Our NeuroSAFE approach included the whole laterorectal circum-ference of the prostate to determine the SM status of the complete neurovascular tissue-corresponding prostatic surface.Outcome measurements and statistical analysis: The impact of NeuroSAFE on NSfrequency, SM status, and biochemical recurrence (BCR) was analyzed by chi-squaretest, and by Kaplan-Meier analyses in propensity score–based matched cohorts.Results and limitations: Positive SMs (PSMs) were detected in 1368 (25%) NeuroSAFERPs, leading to a secondary resection of the ipsilateral neurovascular tissue. Secondarywide resection resulted in conversion to a definitive negative SM (NSM) status in 1180(86%) patients. In NeuroSAFE RPs, frequency of NS was significantly higher (all stages:97% vs 81%; pT2: 99% vs 92%; pT3a: 94% vs 72%; pT3b: 88% vs 40%; p < 0.0001) and PSMrates were significantly lower (all stages: 15% vs 22%; pT2: 7% vs 12%; pT3a: 21% vs 32%;p < 0.0001) than in the matched non-NeuroSAFE RPs. In propensity score–based com-parisons, NeuroSAFE had no negative impact on BCR (pT2, p = 0.06; pT3a, p = 0.17, pT3b,p = 0.99), and BCR-free survival of patients with conversion to NSM did not differsignificantly from patients with primarily NSM (pT2, p = 0.16; pT3, p = 0.26).

y These authors contributed equally to this work and therefore share first authorship.* Corresponding author. Martini-Clinic, Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany. Tel. +49 40 7410 1300; Fax: +49 40 7410 1323.E-mail address: [email protected] (T. Schlomm).

0302-2838/$ – see back matter # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.eururo.2012.04.057

NeuroSafe – technique to reduce positive surgical margin during Robotic Prostatectomy

Surgery in Motion

Neurovascular Structure-adjacent Frozen-section Examination(NeuroSAFE) Increases Nerve-sparing Frequency and ReducesPositive Surgical Margins in Open and Robot-assistedLaparoscopic Radical Prostatectomy: Experience After 11 069Consecutive Patients

Thorsten Schlomm a,b,y,*, Pierre Tennstedt a,y, Caroline Huxhold a,y, Thomas Steuber a,Georg Salomon a, Uwe Michl a, Hans Heinzer a, Jens Hansen a, Lars Budaus a, Stefan Steurer c,Corinna Wittmer c, Sarah Minner c, Alexander Haese a, Guido Sauter c, Markus Graefen a,Hartwig Huland a

a Martini-Clinic, Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; b Department of Urology, Section for

Translational Prostate Cancer Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; c Institute of Pathology, University Medical

Center Hamburg-Eppendorf, Hamburg, Germany




Article info

Article history:Accepted April 29, 2012Published online ahead ofprint on May 10, 2012

Keywords:ProstateProstate cancerNerve-sparing radicalprostatectomySurgeryNerve-sparingFrozen sectionSurgical marginPropensity score

Please visitwww.europeanurology.com andwww.urosource.com to view theaccompanying video.

Abstract

Background: Intraoperative frozen-section analysis allows real-time histologic assess-ment of surgical margins (SMs) and identification of candidates for nerve-sparing (NS)procedures.Objective: To examine the efficacy and oncologic safety of a systematic neurovascularstructure-adjacent frozen-section examination (NeuroSAFE) during NS radical prosta-tectomy (RP).Design, setting, and participants: From January 2002 to June 2011, 11 069 consecutiveRPs were performed at the University Medical Center Hamburg-Eppendorf. Of these,5392 (49%) were conducted with NeuroSAFE.Surgical procedure: Our NeuroSAFE approach included the whole laterorectal circum-ference of the prostate to determine the SM status of the complete neurovascular tissue-corresponding prostatic surface.Outcome measurements and statistical analysis: The impact of NeuroSAFE on NSfrequency, SM status, and biochemical recurrence (BCR) was analyzed by chi-squaretest, and by Kaplan-Meier analyses in propensity score–based matched cohorts.Results and limitations: Positive SMs (PSMs) were detected in 1368 (25%) NeuroSAFERPs, leading to a secondary resection of the ipsilateral neurovascular tissue. Secondarywide resection resulted in conversion to a definitive negative SM (NSM) status in 1180(86%) patients. In NeuroSAFE RPs, frequency of NS was significantly higher (all stages:97% vs 81%; pT2: 99% vs 92%; pT3a: 94% vs 72%; pT3b: 88% vs 40%; p < 0.0001) and PSMrates were significantly lower (all stages: 15% vs 22%; pT2: 7% vs 12%; pT3a: 21% vs 32%;p < 0.0001) than in the matched non-NeuroSAFE RPs. In propensity score–based com-parisons, NeuroSAFE had no negative impact on BCR (pT2, p = 0.06; pT3a, p = 0.17, pT3b,p = 0.99), and BCR-free survival of patients with conversion to NSM did not differsignificantly from patients with primarily NSM (pT2, p = 0.16; pT3, p = 0.26).

y These authors contributed equally to this work and therefore share first authorship.* Corresponding author. Martini-Clinic, Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany. Tel. +49 40 7410 1300; Fax: +49 40 7410 1323.E-mail address: [email protected] (T. Schlomm).

0302-2838/$ – see back matter # 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.eururo.2012.04.057

Our experience with on-table frozen section

!   N=14 patients

!   Commenced procedure in November 2012

!   All patients were intermediate and high risk

!   All patients had intrafascial nerve spares

!   Our T2 positive margin rates are 0% from 18%

!   Our T3 positive margin rates are 17% from 28%

!   Adds a mean of 17 minutes to operative times

Intraoperative outcomes

!   Duration of operative time is used as a marker of the learning curve with RRP

!   With time all series have a reduction in the operative times and console times

!   Operative times were shorter in the RRP when compared to LRP

Operative times Robotic Prostatectomy Operative times laparoscopic Prostatectomy

170 +/- 34.2 min

235 +/- 49.9 min p<0.001

Our experience

Intraoperative Blood loss !   Virtually all published reports confirm a reduction in blood

loss RRP

!   The reason for reduced blood loss

!   Pneumoperitoneum

!   DVC dissection reserved till the end of procedure

DVC ligation and suturing

Late complications Kowalczyk; EUROPEAN UROLOGY 61 (2012) 803–809

Complication MIRP n=11108 RRP n=45227 P value

Anastomotic stricture 3% 9.3% <0.001

Ureteral injury 0.5% 1.3% <0.001

Recto-urethral fistula 0.4% 0.4% 0.999

Lymphocoele 1.3% 2.2% <0.001

Surgery for incontinence 0.3% 0.3% 0.734

Platinum Priority – Review – Prostate CancerEditorial by Peter C. Albertsen on pp. 365–367 of this issue

Systematic Review and Meta-analysis of Perioperative Outcomesand Complications After Robot-assisted Radical Prostatectomy

Giacomo Novara a,*, Vincenzo Ficarra a,b, Raymond C. Rosen c, Walter Artibani d,Anthony Costello e, James A. Eastham f, Markus Graefen g, Giorgio Guazzoni h,Shahrokh F. Shariat i, Jens-Uwe Stolzenburg j, Hendrik Van Poppel k, Filiberto Zattoni a,Francesco Montorsi l, Alexandre Mottrie b, Timothy G. Wilson m

a University of Padua, Padua, Italy; b O.L.V. Robotic Surgery Institute, Aalst, Belgium; c Department of Epidemiology, New England Research Institutes, Inc.,

Watertown, MA, USA; d University of Verona, Verona, Italy; e Royal Melbourne Hospital, Grattan Street, Melbourne, Australia; f Memorial Sloan-Kettering

Cancer Center, New York, NY, USA; g Martini-Clinic, Prostate Cancer Centre, University Hamburg-Eppendorf, Hamburg, Germany; h University Vita-Salute San

Raffaele, H. San Raffaele-Turro, Milan, Italy; i Weill Medical College of Cornell University, New York, NY, USA; j University of Leipzig, Leipzig, Germany;k University Hospital, Katholieke Universiteit Leuven, Leuven, Belgium; l University Vita-Salute San Raffaele, H. San Raffaele, Milan, Italy; m City of Hope

National Cancer Center, Duarte, CA, USA




Article info

Article history:Accepted May 22, 2012Published online ahead ofprint on June 2, 2012

Keywords:Prostatic neoplasmsProstatectomyLaparoscopyRobotics

Abstract

Context: Perioperative complications are a major surgical outcome for radical prosta-tectomy (RP).Objective: Evaluate complication rates following robot-assisted RP (RARP), risk factorsfor complications after RARP, and surgical techniques to improve complication ratesafter RARP. We also performed a cumulative analysis of all studies comparing RARP withretropubic RP (RRP) or laparoscopic RP (LRP) in terms of perioperative complications.Evidence acquisition: A systematic review of the literature was performed in August2011, searching Medline, Embase, and Web of Science databases. A free-text protocol usingthe term radical prostatectomy was applied. The following limits were used: humans;gender (male); and publications dating from January 1, 2008. A cumulative analysis wasconducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK).Evidence synthesis: We retrieved 110 papers evaluating oncologic outcomes followingRARP. Overall mean operative time is 152 min; mean blood loss is 166 ml; meantransfusion rate is 2%; mean catheterization time is 6.3 d; and mean in-hospital stayis 1.9 d. The mean complication rate was 9%, with most of the complications being of lowgrade. Lymphocele/lymphorrea (3.1%), urine leak (1.8%), and reoperation (1.6%) are themost prevalent surgical complications. Blood loss (weighted mean difference: 582.77;p < 0.00001) and transfusion rate (odds ratio [OR]: 7.55; p < 0.00001) were lower inRARP than in RRP, whereas only transfusion rate (OR: 2.56; p = 0.005) was lower in RARPthan in LRP. All the other analyzed parameters were similar, regardless of the surgicalapproach.Conclusions: RARP can be performed routinely with a relatively small risk of complica-tions. Surgical experience, clinical patient characteristics, and cancer characteristics mayaffect the risk of complications. Cumulative analyses demonstrated that blood loss andtransfusion rates were significantly lower with RARP than with RRP, and transfusionrates were lower with RARP than with LRP, although all other features were similarregardless of the surgical approach.

# 2012 Published by Elsevier B.V. on behalf of European Association of Urology.

* Corresponding author. Department of Surgical and Oncological Sciences, Urologic Unit,Via Giustiniani 2, 35100 Padua, Italy. Tel. +39 049 8212720; Fax: +39 049 8218757.E-mail address: [email protected], [email protected] (G. Novara).

0302-2838/$ – see back matter # 2012 Published by Elsevier B.V. on behalf of European Association of Urology.http://dx.doi.org/10.1016/j.eururo.2012.05.044

•  110 papers evaluating oncologic outcomes following RARP

•  Overall mean operative time is 152 min

•  Mean blood loss is 166 ml •  Mean transfusion rate is 2%

•  Mean catheterization time is 6.3 d

•  Mean in-hospital stay is 1.9 d


Systematic Review and Meta-analysis of Perioperative Outcomesand Complications After Robot-assisted Radical Prostatectomy

Giacomo Novara a,*, Vincenzo Ficarra a,b, Raymond C. Rosen c, Walter Artibani d,Anthony Costello e, James A. Eastham f, Markus Graefen g, Giorgio Guazzoni h,Shahrokh F. Shariat i, Jens-Uwe Stolzenburg j, Hendrik Van Poppel k, Filiberto Zattoni a,Francesco Montorsi l, Alexandre Mottrie b, Timothy G. Wilson m

a University of Padua, Padua, Italy; b O.L.V. Robotic Surgery Institute, Aalst, Belgium; c Department of Epidemiology, New England Research Institutes, Inc.,

Watertown, MA, USA; d University of Verona, Verona, Italy; e Royal Melbourne Hospital, Grattan Street, Melbourne, Australia; f Memorial Sloan-Kettering

Cancer Center, New York, NY, USA; g Martini-Clinic, Prostate Cancer Centre, University Hamburg-Eppendorf, Hamburg, Germany; h University Vita-Salute San

Raffaele, H. San Raffaele-Turro, Milan, Italy; i Weill Medical College of Cornell University, New York, NY, USA; j University of Leipzig, Leipzig, Germany;k University Hospital, Katholieke Universiteit Leuven, Leuven, Belgium; l University Vita-Salute San Raffaele, H. San Raffaele, Milan, Italy; m City of Hope

National Cancer Center, Duarte, CA, USA




Article info

Article history:Accepted May 22, 2012Published online ahead ofprint on June 2, 2012


Abstract

Context: Perioperative complications are a major surgical outcome for radical prosta-tectomy (RP).Objective: Evaluate complication rates following robot-assisted RP (RARP), risk factorsfor complications after RARP, and surgical techniques to improve complication ratesafter RARP. We also performed a cumulative analysis of all studies comparing RARP withretropubic RP (RRP) or laparoscopic RP (LRP) in terms of perioperative complications.Evidence acquisition: A systematic review of the literature was performed in August2011, searching Medline, Embase, and Web of Science databases. A free-text protocol usingthe term radical prostatectomy was applied. The following limits were used: humans;gender (male); and publications dating from January 1, 2008. A cumulative analysis wasconducted using Review Manager software v.4.2 (Cochrane Collaboration, Oxford, UK).Evidence synthesis: We retrieved 110 papers evaluating oncologic outcomes followingRARP. Overall mean operative time is 152 min; mean blood loss is 166 ml; meantransfusion rate is 2%; mean catheterization time is 6.3 d; and mean in-hospital stayis 1.9 d. The mean complication rate was 9%, with most of the complications being of lowgrade. Lymphocele/lymphorrea (3.1%), urine leak (1.8%), and reoperation (1.6%) are themost prevalent surgical complications. Blood loss (weighted mean difference: 582.77;p < 0.00001) and transfusion rate (odds ratio [OR]: 7.55; p < 0.00001) were lower inRARP than in RRP, whereas only transfusion rate (OR: 2.56; p = 0.005) was lower in RARPthan in LRP. All the other analyzed parameters were similar, regardless of the surgicalapproach.Conclusions: RARP can be performed routinely with a relatively small risk of complica-tions. Surgical experience, clinical patient characteristics, and cancer characteristics mayaffect the risk of complications. Cumulative analyses demonstrated that blood loss andtransfusion rates were significantly lower with RARP than with RRP, and transfusionrates were lower with RARP than with LRP, although all other features were similarregardless of the surgical approach.

# 2012 Published by Elsevier B.V. on behalf of European Association of Urology.

* Corresponding author. Department of Surgical and Oncological Sciences, Urologic Unit,Via Giustiniani 2, 35100 Padua, Italy. Tel. +39 049 8212720; Fax: +39 049 8218757.E-mail address: [email protected], [email protected] (G. Novara).


•  The mean complication rate was 9%, with most of the complications being of low grade

•  Lymphocele/lymphorrea (3.1%), urine leak (1.8%), and reoperation (1.6%) are the most prevalent surgical complications

•  Blood loss (weighted mean difference: 582.77; p < 0.00001) and transfusion rate (odds ratio [OR]: 7.55; p < 0.00001) were lower in RARP than in RRP, whereas only transfusion rate (OR: 2.56; p = 0.005) was lower in RARP than in LRP

•  RARP can be performed routinely with a relatively small risk of complications. Surgical experience, clinical patient characteristics, and cancer characteristics may affect the risk of complications

Continence


Systematic Review and Meta-analysis of Studies ReportingUrinary Continence Recovery After Robot-assisted RadicalProstatectomy

Vincenzo Ficarra a,b,*, Giacomo Novara a, Raymond C. Rosen c, Walter Artibani d,Peter R. Carroll e, Anthony Costello f, Mani Menon g, Francesco Montorsi h, Vipul R. Patel i,Jens-Uwe Stolzenburg j, Henk Van der Poel k, Timothy G. Wilson l, Filiberto Zattoni a,Alexandre Mottrie b

a University of Padua, Padua, Italy; b O.L.V. Clinic, Aalst, Belgium; c New England Research Institutes, Inc., Watertown, MA, USA; d University of Verona,

Verona, Italy; e University of California, San Francisco, CA, USA; f Royal Melbourne Hospital, Melbourne, Australia; g Henry Ford Hospital, Detroit, MI, USA;h Vita-Salute San Raffaele University, Milan, Italy; i Global Robotic Institute, Florida Hospital Celebration Health, Orlando, FL, USA; j University of Leipzig,

Leipzig, Germany; k Netherlands Cancer Institute, Amsterdam, The Netherlands; l City of Hope Cancer Center, Duarte, CA, USA




Article info

Article history:Accepted May 22, 2012Published online ahead ofprint on May 31, 2012


Please visitwww.eu-acme.org/europeanurology to read andanswer questions on-line.The EU-ACME credits willthen be attributedautomatically.

Abstract

Context: Robot-assisted radical prostatectomy (RARP) was proposed to improve func-tional outcomes in comparison with retropubic radical prostatectomy (RRP) or laparo-scopic radical prostatectomy (LRP). In the initial RARP series, 12-mo urinary continencerecovery rates ranged from 84% to 97%. However, the few available studies comparing RARPwith RRP or LRP published before 2008 did not permit any definitive conclusions about thesuperiority of any one of these techniques in terms of urinary continence recovery.Objective: The aims of this systematic review were (1) to evaluate the prevalence andrisk factors for urinary incontinence after RARP, (2) to identify surgical techniquesable to improve urinary continence recovery after RARP, and (3) to perform a cumulativeanalysis of all available studies comparing RARP versus RRP or LRP in terms of theurinary continence recovery rate.Evidence acquisition: A literature search was performed in August 2011 using theMedline, Embase, and Web of Science databases. The Medline search included only afree-text protocol using the term radical prostatectomy across the title and abstract fieldsof the records. The following limits were used: humans; gender (male); and publicationdate from January 1, 2008. Searches of the Embase and Web of Science databases usedthe same free-text protocol, keywords, and search period. Only comparative studies orclinical series including >100 cases reporting urinary continence outcomes wereincluded in this review. Cumulative analysis was conducted using the Review Managerv.4.2 software designed for composing Cochrane Reviews (Cochrane Collaboration,Oxford, UK).Evidence synthesis: We analyzed 51 articles reporting urinary continence rates afterRARP: 17 case series, 17 studies comparing different techniques in the context of RARP,9 studies comparing RARP with RRP, and 8 studies comparing RARP with LRP. The 12-mourinary incontinence rates ranged from 4% to 31%, with a mean value of 16% using ano pad definition. Considering a no pad or safety pad definition, the incidence ranged from8% to 11%, with a mean value of 9%. Age, body mass index, comorbidity index, lowerurinary tract symptoms, and prostate volume were the most relevant preoperative

* Corresponding author. Department of Surgical and Oncological Sciences, Urologic Unit,Via Giustiniani 2, 35100 Padua, Italy. Tel. +39 049 8212720; Fax: +39 049 8218757.E-mail address: [email protected] (V. Ficarra).











Article info




Abstract




•  51 articles reporting urinary continence rates after RARP •  The 12-mo urinary incontinence rates ranged from 4% to 31%, with a

mean value of 16% using a no pad definition. •  Posterior musculofascial reconstruction with or without anterior

reconstruction was associated with a small advantage in urinary continence recovery 1 mo after RARP.

•  Only complete reconstruction was associated with a significant advantage in urinary continence 3 mo after RARP (odds ratio [OR]: 0.76; p=0.04)

•  Cumulative analyses showed a better 12-mo urinary continence recovery after RARP in comparison with RRP (OR: 1.53; p=0.03) or LRP (OR: 2.39; p=0.006)










Article info




Abstract




•  The prevalence of urinary incontinence after RARP is influenced

by preoperative patient characteristics, surgeon experience, surgical technique, and methods used to collect and report data

•  Posterior musculofascial reconstruction seems to offer a slight advantage in terms of 1-mo urinary continence recovery

•  Update of a previous systematic review of literature shows, for the first time, a statistically significant advantage in favor of RARP in comparison with both RRP and LRP in terms of 12-mo urinary continence recovery

Cost

Cost

Cost

Intuitive sales

What makes robotic surgery expensive ?

!   The initial cost is extremely high, estimated to be about $1.8 million and the maintenance costs

!   After ten uses of a robot, the instruments must be replaced

!   Use of the robot comes with a slower learning curve for doctors.

!   When hospitals attempt to balance patient safety with the high training costs, sometimes poor patient outcomes occur.

!   There are also increased costs to the patient per surgery, estimated at around $2,500 per procedure compared to traditional methods

Robotic prostatectomy will always be more costly to the NHS because of the fixed capital and maintenance charges for the robotic system Our modelling showed that this excess cost can be reduced if capital costs of equipment are minimised and by maintaining a high case volume for each robotic system of at least 100–150 procedures per year. This finding was primarily driven by a difference in positive margin rate

How can we improve robotic surgical outcomes

!   Regulation of Training

How can we improve robotic surgical outcomes

!   Simulation !   Simulation and Technology enhanced Learning Initiative

(STeLI) project

!   SAGES / RAST (Robotic assisted surgical training) programme

!   Formal Fellowship training !   6 robotic fellowships in the UK

!   Only one recognized by the RCS/BAUS

!   Strict audit of outcomes

Latest developments !   Robotic image integration surgery (Imris medical)

Latest Developments

!   Haptic Feedback

Latest Developments

Robotic Prostatectomy- Is the jury out ?

Conclusion

!   Men undergoing a Robotic Prostatectomy appear to have :-

!   Lower intraoperative blood loss

!   Reduced surgical morbidity

!   Lower risk of a positive margin

!   Reduced risk of cancer recurrence and hence need to further treatment

!   Oncological outcomes are equivalent

!   No evidence that men undergoing a RRP are disadvantaged in terms of functional outcomes

!   Longer follow up is required to relative effectiveness

Conclusion

“The Surgeon is the most important determinant of robotic radical prostatectomy outcomes of peri-operative

complications, length of stay and strictures”

L Klotz

“The aim now should be to evaluate the cost of robotic prostatectomy results in long term gain for patient”

J Meeks

Correspondence !   Mr Nikhil Vasdev

Post CCT Robotic Urological Fellow (RCSEng/BAUS National Accredited Fellowship Programme) Hertfordshire and South Bedfordshire Urological Cancer Centre Lister Hospital Stevenage UK

Email – [email protected] Website – www.roboticsinsurgery.org

Date post:	14-Dec-2014
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Robotic prostatectomy – The way forward or is the jury still out ?

Health & Medicine